Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

NCT ID: NCT03498352

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2021-01-31

Brief Summary

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Cardiopulmonary exercise testing is recommended for preoperative evaluation and risk stratification of lung resection candidates. Ventilatory efficiency (VE/VCO2 slope) has been shown to predict morbidity and mortality in lung resection candidates and has been shown superior to peak oxygen consumption (VO2). Patients with increased VE/VCO2 during exercise also exhibit increased VE/VCO2 ratio and decreased end-tidal CO2 at rest. Our first hypothesis is that rest ventilatory parameters predict morbidity and mortality in patients undergoing thoracic surgery. VE/VCO2 is well correlated with ventilation-perfusion mismatch, therefore it may be useful in hypoxemia prediction during one-lung ventilation during thoracic surgery. Our second hypothesis is that patients with high VE/VCO2 will be prone to hypoxemia development during one-lung ventilation.

Detailed Description

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Conditions

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Pulmonary Complication Cardiovascular Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Thoracic surgery

Lung resection surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* thoracotomy because of lung infiltration (confirmed or highly suspicious lung tumor)

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Ivan Cundrle

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Cundrle, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Anne's University Hospital Brno

Locations

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University Hospital Brno

Brno, Czech Republic, Czechia

Site Status

St. Anne's University Hospital Brno

Brno, Czech Republic, Czechia

Site Status

Countries

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Czechia

References

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Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.

Reference Type BACKGROUND
PMID: 22560968 (View on PubMed)

Choi H, Mazzone P. Preoperative evaluation of the patient with lung cancer being considered for lung resection. Curr Opin Anaesthesiol. 2015 Feb;28(1):18-25. doi: 10.1097/ACO.0000000000000149.

Reference Type BACKGROUND
PMID: 25486485 (View on PubMed)

Brunelli A, Charloux A, Bolliger CT, Rocco G, Sculier JP, Varela G, Licker M, Ferguson MK, Faivre-Finn C, Huber RM, Clini EM, Win T, De Ruysscher D, Goldman L; European Respiratory Society and European Society of Thoracic Surgeons joint task force on fitness for radical therapy. ERS/ESTS clinical guidelines on fitness for radical therapy in lung cancer patients (surgery and chemo-radiotherapy). Eur Respir J. 2009 Jul;34(1):17-41. doi: 10.1183/09031936.00184308.

Reference Type BACKGROUND
PMID: 19567600 (View on PubMed)

Arena R, Myers J, Aslam SS, Varughese EB, Peberdy MA. Peak VO2 and VE/VCO2 slope in patients with heart failure: a prognostic comparison. Am Heart J. 2004 Feb;147(2):354-60. doi: 10.1016/j.ahj.2003.07.014.

Reference Type BACKGROUND
PMID: 14760336 (View on PubMed)

Cundrle I Jr, Johnson BD, Rea RF, Scott CG, Somers VK, Olson LJ. Modulation of ventilatory reflex control by cardiac resynchronization therapy. J Card Fail. 2015 May;21(5):367-373. doi: 10.1016/j.cardfail.2014.12.013. Epub 2015 Jan 8.

Reference Type BACKGROUND
PMID: 25576681 (View on PubMed)

Cundrle I Jr, Somers VK, Johnson BD, Scott CG, Olson LJ. Exercise end-tidal CO2 predicts central sleep apnea in patients with heart failure. Chest. 2015 Jun;147(6):1566-1573. doi: 10.1378/chest.14-2114.

Reference Type BACKGROUND
PMID: 25742609 (View on PubMed)

Guenoun T, Journois D, Silleran-Chassany J, Frappier J, D'attellis N, Salem A, Safran D. Prediction of arterial oxygen tension during one-lung ventilation: analysis of preoperative and intraoperative variables. J Cardiothorac Vasc Anesth. 2002 Apr;16(2):199-203. doi: 10.1053/jcan.2002.31067.

Reference Type BACKGROUND
PMID: 11957171 (View on PubMed)

Hurford WE, Alfille PH. A quality improvement study of the placement and complications of double-lumen endobronchial tubes. J Cardiothorac Vasc Anesth. 1993 Oct;7(5):517-20. doi: 10.1016/1053-0770(93)90305-5.

Reference Type BACKGROUND
PMID: 8268428 (View on PubMed)

Schwarzkopf K, Klein U, Schreiber T, Preussetaler NP, Bloos F, Helfritsch H, Sauer F, Karzai W. Oxygenation during one-lung ventilation: the effects of inhaled nitric oxide and increasing levels of inspired fraction of oxygen. Anesth Analg. 2001 Apr;92(4):842-7. doi: 10.1097/00000539-200104000-00009.

Reference Type BACKGROUND
PMID: 11273912 (View on PubMed)

Slinger P, Suissa S, Triolet W. Predicting arterial oxygenation during one-lung anaesthesia. Can J Anaesth. 1992 Dec;39(10):1030-5. doi: 10.1007/BF03008370.

Reference Type BACKGROUND
PMID: 1464128 (View on PubMed)

Slinger P, Triolet W, Wilson J. Improving arterial oxygenation during one-lung ventilation. Anesthesiology. 1988 Feb;68(2):291-5. doi: 10.1097/00000542-198802000-00022. No abstract available.

Reference Type BACKGROUND
PMID: 3277487 (View on PubMed)

Katz Y, Zisman E, Isserles SA, Rozenberg B. Left, but not right, one-lung ventilation causes hypoxemia during endoscopic transthoracic sympathectomy. J Cardiothorac Vasc Anesth. 1996 Feb;10(2):207-9. doi: 10.1016/s1053-0770(96)80238-2.

Reference Type BACKGROUND
PMID: 8850398 (View on PubMed)

Yokota K, Toriumi T, Sari A, Endou S, Mihira M. Auto-positive end-expiratory pressure during one-lung ventilation using a double-lumen endobronchial tube. Anesth Analg. 1996 May;82(5):1007-10. doi: 10.1097/00000539-199605000-00021.

Reference Type BACKGROUND
PMID: 8610857 (View on PubMed)

Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.

Reference Type BACKGROUND
PMID: 19417615 (View on PubMed)

Nomoto Y. Preoperative pulmonary blood flow and one-lung anaesthesia. Can J Anaesth. 1987 Sep;34(5):447-9. doi: 10.1007/BF03014346.

Reference Type BACKGROUND
PMID: 3664910 (View on PubMed)

Woods PR, Olson TP, Frantz RP, Johnson BD. Causes of breathing inefficiency during exercise in heart failure. J Card Fail. 2010 Oct;16(10):835-42. doi: 10.1016/j.cardfail.2010.05.003. Epub 2010 Jun 16.

Reference Type BACKGROUND
PMID: 20932466 (View on PubMed)

Filakovszky A, Brat K, Tschoellitsch T, Bartos S, Mazur A, Meier J, Olson L, Cundrle I. Cardiopulmonary exercise testing before lung resection surgery: still indicated? Evaluating predictive utility using machine learning. Thorax. 2025 Oct 2:thorax-2024-221485. doi: 10.1136/thorax-2024-221485. Online ahead of print.

Reference Type DERIVED
PMID: 41043965 (View on PubMed)

Brat K, Chobola M, Homolka P, Heroutova M, Benej M, Mitas L, Olson LJ, Cundrle I. Poor ventilatory efficiency during exercise may predict prolonged air leak after pulmonary lobectomy. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):269-272. doi: 10.1093/icvts/ivz255.

Reference Type DERIVED
PMID: 31630177 (View on PubMed)

Other Identifiers

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IIT/2017/12 and 2018/08

Identifier Type: -

Identifier Source: org_study_id

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